MHRA posts suite of post-transition guidances
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical trials and more will be regulated after the Brexit transition period expires on 1 January 2021.Clinical trials
Two guidances related to clinical trials explain requirements for the registration of clinical trials for investigational medicinal products and the submission of substantial amendments to clinical trials.
Sponsors should continue using established international registers, including the ISRCTN registry or the US’s clinicaltrials.gov and instructions are provided for the timeframes for trial registration and registration deferral. Sponsors are also instructed to publish summaries of trial results within six months for pediatric studies and within one year for adult trials.
The guidance on substantial amendments explains when a substantial amendment is needed depending on the location of the trial sponsor or legal representative or when there are changes related to the certification and importation of investigational medicinal products. MHRA says it will provide details on a protocol for Northern Ireland “in due course.”
Medical devices
MRHA’s guidance on medical devices explains post-transition information on device certification, conformity marking and registration with the agency.
Notably, the agency says that the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will “not automatically apply in Great Britain,” as they will not take effect in the EU until after the transition period expires.
MRHA says the UK has “the opportunity to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety,” and that it “will take into consideration international standards and global harmonisation in the development of our future system.” The agency says it will consult with stakeholders on a future regime this autumn.
CE marking will continue to be recognized until 30 June 2023, as will certificates issued by European Economic Area-based notified bodies.
Beginning on 1 January 2021, MHRA says it will offer “a new route to market and product marking … for manufacturers wishing to place a device on the Great Britain market,” and that from that date all devices and in vitro diagnostics (IVDs) placed on the UK market must be registered with the agency. However, certain devices will be given a grace period from the registration requirements:
- Four months:
- Active implantable medical devices
- Class III medical devices
- Class IIb implantable medica devices
- IVD list A
- Eight months:
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD list B
- Self-test IVDs
- 12 months:
- Class I medical devices
- General IVDs
MHRA notes that the 12-month grace period does not apply to Class I devices and general IVDs that must currently be registered.
While the UK will continue to accept CE marked devices for two and a half years after the transition period ends, it will begin rolling out a new UK Conformity Assessed (UKCA) mark on 1 January 2021. On that date, MHRA will be able to designate UK Approved Bodies which can conduct conformity assessments for the purposes of UKCA marking. Existing UK notified bodies will automatically be “rolled over” to UK Approved Bodies.
On 1 July 2023, a UKCA mark will be required for placing medical devices on the Great Britain market, though the requirement will not apply to companies in Northern Ireland. However, the makers of non-sterile or non-measuring Class I devices and general IVDs may self-declare conformity against Part II and Part IV of the UK MDR 2002.
Unlike in Great Britain, the EU MDR and IVDR will apply in Northern Ireland according to the EU’s implementation timeline.
Licensing
The post-transition guidances include 12 documents explaining how various aspects of pharmaceutical and biological product licensing will work beginning 1 January 2021.
The guidances include:
- Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021
- Registering new packaging information for medicines from 1 January 2021
- Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021
- How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021
- Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021
- Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021
- Reference Medicinal Products (RMPs) from 1 January 2021
- Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes
- Renewing Marketing Authorisations for medicines from 1 January 2021
- Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
- Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021
- Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021
Importing and exporting
Six guidances explain how the import and export of medicines, active substances and investigational products will work post-transition. A new guidance also provides lists of approved countries for importing medicines, batch testing and those with equivalent regulatory standards for active pharmaceutical ingredient (API) manufacturing.
The guidances also include instructions for applying for a certificate of pharmaceutical products and an explanation of how qualified person (QP)-certified medicines from the EEA may be imported under the supervision of a responsible person (import) (RPi).
Other guidances
The remaining guidances provide advice for registering with MHRA IT systems, pharmacovigilance procedures and pediatric studies and investigation plans post-transition.
The pediatric guidances cover procedures for UK pediatric investigation plans (PIPs), the handling of completed pediatric studies and PIP applications, waivers and deferrals.